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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE HOMEPUMP C-SERIES, 270 ML, 5 ML/HR (CONTAINS DEHP); ELASTOMERIC LFR

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AVANOS MEDICAL - IRVINE HOMEPUMP C-SERIES, 270 ML, 5 ML/HR (CONTAINS DEHP); ELASTOMERIC LFR Back to Search Results
Model Number C270050
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 11-dec-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Avanos medical inc has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc complaint database and identified as complaint (b)(4).
 
Event Description
Avanos medical received a single report that referenced five different incidents, which were associated with separate units, involving an unknown number of patients.This is the third of five reports.Refer to 2026095-2018-00160 for the first event.Refer to 2026095-2018-00161 for the second event.Refer to 2026095-2018-00163 for the fourth event.Refer to 2026095-2018-00164 for the fifth event.Fill volume: 250 ml, flow rate: unknown, procedure: unknown, cathplace: unknown.It was reported that a patient experienced a homepump that completed its infusion 12 hours early.No reported patient toxicity occurred.
 
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Brand Name
HOMEPUMP C-SERIES, 270 ML, 5 ML/HR (CONTAINS DEHP)
Type of Device
ELASTOMERIC LFR
Manufacturer (Section D)
AVANOS MEDICAL - IRVINE
43 discovery
suite 100
irvine CA 92618
Manufacturer (Section G)
AVENT S. DE R.L. DE C.V.
ave noruega edificio d-1b
fraccionamiento rubio
tijuana b.c. 22116
MX   22116
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta 30004
4704485444
MDR Report Key8158589
MDR Text Key131311466
Report Number2026095-2018-00162
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 11/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberC270050
Device Catalogue Number101356800
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/21/2018
Initial Date FDA Received12/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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